反相高效液相色谱法测定利斯的明胶囊的溶出度

目的:建立测定利斯的明溶出度的反相高效液相色谱(RP-HPLC)法。方法:采用Agilent 1100型高效液相色谱仪,DiamonsilTM C18柱(150 mm×4．0 mm,5μm),以0．025 mol·L-1磷酸二氢钾／0．1％三乙胺(pH=6．7):乙腈=72:28(V／V)为流动相,流速1．0 mL·min-1,检测波长263 nm。结果:利斯的明在3．604～530 mg·L-1范围内呈良好的线性关系(r=0．999 9,n=5),平均回收率在99％～101％之间,精密度尺RSD<5％,样品稳定性好。45 min三批胶囊溶出度均在70％以上,符合规定。结论:本方法结果准确,重复性好,方法简便可行。

Determination of dissolution of rivastigmine by reverse-phase high performance liquid chromatography

To establish a reversed-phase HPLC method for the determination of dissolution of riva-stigmine. METHODS: Chromatographic analyses were performed on an Agilent 1100 LC system and a Diamon-sil C18 analytical column (150×4.0 mm, i.d. 5μm) . The mobile phase consisted of 0.025 mol·L-1 KH2PO4/ 0.1 % triethylamine (pH = 6.7) : acetonitrile (72 : 28, V/V) and flow rate was 1.0 mL·min-1. The detection wavelength was 263 nm. RESULTS: Rivastigmine showed good linear relationship within the range of 3.604 -530 mg·L-1 (r = 0.999 9, n = 5) with average recoveries of 99 % - 101 % and RSD of intra- and inter-day assays lower than 5 %, and still more possessing good stability. The dissolutions of three batches of capsules at 45 min were greater than 75 % coinciding with the qualification. CONCLUSION: The reversed-phase HPLC method for the determination of rivastigmine is accurate, simple, and reproducible.